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National Medical Devices Policy 2023: A New Paradigm Shift

08 May 2023

On April 26, 2023, the Union Cabinet, chaired over by the Hon’ble PM Modi, approved the National Medical Devices Policy, 2023, laying the groundwork for India’s medical devices sector to become not only self-sufficient but also a global leader, while achieving broader public health objectives of access, affordability, quality, innovation, and universal health coverage.

With sector’s significant contribution in battling against the COVID-19 pandemic, it has now been considered as a sunrise sector with enough growth potentials as well as playing an integral role in India’s healthcare particularly for the prevention, diagnosis, treatment and management of all medical conditions, diseases, illnesses, and disabilities.

In recognition of this inherent potential, a separate policy has been approved with the objective of creating an ecosystem conducive to medical device manufacturing, with an emphasis on innovation, creating a robust and streamlined regulatory framework, providing support in training and capacity building programmes, and promoting higher education to foster talent and skilled resources in line with industry requirements.

Therefore, the move will undoubtedly be a significant lift to the industry’s performance in terms of addressing industry’s long-standing concerns and improving manufacturing, innovation, Ease of Doing Business, and competitiveness in a sector that largely remained outside the regulatory ambit until 2017.

Envisioned to achieve 10-12% share in the global market over the next 25 years as well as growth of $50 Bn by 2030, the policy has laid down a holistic framework and a roadmap for accelerated growth of the medical devices sector to achieve following missions viz, Access & Universality, Affordability, Quality, Patient Centered & Quality Care, Preventive & Promotive Health, Security, Research and Innovation and Skilled manpower.

A set of strategies have been devised to maximize the sector’s potential and effectively facilitate and direct it: –

Regulatory Streamlining: To ease research and business and balance patient safety with product innovation, a Single Window Clearance System for Medical Device Licencing involving all stakeholder departments/organizations, enhancing the role of Indian Standards like BIS, and designing a coherent pricing regulation will be implemented.

Enabling Infrastructure: Efforts towards building a robust infrastructure through establishment of large medical device parks, clusters equipped with world class common infrastructure facilities in proximity to economic zones with requisite logistics connectivity as envisioned under the National Industrial Corridor Program and the proposed National Logistics Policy 2021 under the ambit of PM Gati Shakti would be pursued with the State Governments and Industry.

Facilitating R&D and Innovation: Promotion of R&D through Department’s proposed National Policy on R&D and Innovation in the Pharma- MedTech Sector in India is on cards. Centres of Excellence at universities and research facilities, innovation nodes, ‘plug and play’ infrastructures, and help for start-ups are all part of the plan.

Attracting Investments in the Sector: The policy encourages private investments, venture capital financing series, and public-private partnerships.

Human Resources Development: Skilling, reskilling and upskilling of professionals in the medical device sector, supporting dedicated multidisciplinary courses for medical devices in existing institutions; conducting cutting-edge manufacturing and research; forging partnerships with international academic/industry organizations to create cutting-edge medical technologies are all the long-term objectives of the policy.

Brand Positioning and Awareness Creation: The policy envisages the creation of a dedicated Export Promotion Council which will be an enabler to deal with various market access issue.

This historic step has the complete backing of the business community, which is prepared to bring convergence in the efforts for sector’s systematic development and expansion.

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